Evaluation of Oral Glucose Tolerance Testing in Patients With Post-pancreatitis Diabetes Mellitus for Diagnosis and Characterization: a Cross-sectional Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- steamed bun meal test result 3
研究概览
简要总结
To evaluate the islet function and insulin secretion pattern of post-pancreatitis diabetes mellitus by oral glucose tolerance testing, and to explore the pathophysiological characteristics of PPDM-C which provide evidence for the diagnosis of PPDM-C.
详细描述
Blood samples will be collected from patients with chronic pancreatitis by oral glucose tolerance test (steamed bun meal test, SBMT) to assess their pancreatic islet function and insulin secretion pattern, measure other intestinal hormones, exosomes, plasma metabolites, and serum biochemical factors to characterize the pathophysiological features of PPDM-C and provide evidence for the diagnosis of PPDM-C. In order to better understand the glycemic fluctuations in patients with chronic pancreatitis combined with diabetes and guide subsequent treatment, Continuous Glucose Monitoring would be used in patients with chronic pancreatitis who had new-onset diabetes or poor glycemic control.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 15 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with the diagnosis of chronic pancreatitis and diabetes mellitus (exclude type 1 diabetes).
- •participants with painless chronic pancreatitis were diagnosed with diabetes within 2 years of the diagnosis of chronic pancreatitis.
- •participants with painful chronic pancreatitis were diagnosed with diabetes after the first attack of chronic pancreatitis.
- •patients with chronic pancreatitis were previously diagnosed type 2 diabetes mellitus for more than 3 years.
排除标准
- •Participants with suspected malignant tumors of the pancreas or other sites of the body (including pancreatic cyst and Benign pancreatic tumor), or participants in the terminal stage of severe disease
- •Prior pancreatic surgery (including total pancreatectomy, pancreaticoduodenectomy, distal pancreatectomy, pancreatojejunostomy, or Frey), and prior bariatric or gastrointestinal surgery.
- •Serious mental illness, lesion of the liver (alanine aminotransferase or aspartate aminotransferase > 3 times the upper reference limit) or kidney (eGFR<60 mL/min/1.73 m2), pregnancy, breastfeeding or planning pregnancy, or accompanied with active liver diseases such as hepatitis B or hepatic cirrhosis.
- •Diagnosed type 1 diabetes, or other metabolic diseases that affect blood glucose
- •Using high-dose insulin preparations, or drugs affecting glucose metabolism (oral steroids, thiazide diuretics, beta-blockers, beta-agonist, nicotinic acid, immunosuppressant agents, antiretroviral drugs, and antipsychotics)
- •Acute complications of diabetes (diabetic ketoacidosis, severe hypoglycemia), severe microvascular disease (proliferative diabetic retinopathy, known diabetic nephropathy or neuropathy requiring treatment), and macrovascular disease (uncontrolled arterial hypertension, uncontrolled coronary artery disease, congestive heart failure, history of cerebrovascular event, seizure disorder, syncope, adrenal insufficiency, neurologic disease or atrial fibrillation) within the 12 months prior to enrollment.
- •Hospitalization for acute pancreatitis within the 2 months prior to enrollment or currently suffering acute inflammation.
- •Have been enrolled or currently participating in other clinical trials within the 3 months prior to enrollment.
- •Patients who refused to participate in the study
结局指标
主要结局
steamed bun meal test result 3
时间窗: Within 7 hours after the end of the steamed bread meal test
Levels of insulin under the steamed bun meal experiment (100g flour made steamed bun)
steamed bun meal test result 2
时间窗: Within 6 hours after the end of the steamed bread meal test
Levels of c-peptide bun meal experiment (100g flour made steamed bun)
steamed bun meal test result 1
时间窗: Within 5 hours after the end of the steamed bread meal test
Levels of glucose under the steamed bun meal experiment (100g flour made steamed bun)
次要结局
- gut hormone(up to 1 month)
- Continuous glucose monitor results(after using continuous glucose monitor device for 7-14 days)
- glycemic control(at the time of enrollment)